摘要
目的:建立HPLC法测定替格瑞洛片中的有关物质的方法。方法:采用Agilent Zorbax SB-C18色谱柱(4.6 mm×150 mm,1.8μm);以磷酸盐缓冲液-乙腈为流动相,梯度洗脱;流量1.0 m L·min-1;柱温55℃;检测波长242 nm。结果:在该色谱条件下,替格瑞洛与各杂质峰分离度良好。结论:建立的方法灵敏度高,专属性强,可用于替格瑞洛片生产中有关物质的检测。
Objective：To develop an HPLC method for the determination of related substances in Ticagrelor Tablets.Methods：The as-say was performed on an Agilent Zorbax SB-C18 column（4.6 mm ×150 mm, 1.8 μm） with phosphate buffer solution-acetonitrile as mobile phase, gradient elution at a flow rate of 1.0 mL· min-1;The column temperature was 55℃and detection wavelength was 242 nm.Results：Ticagrelor and impurity peaks could be well separated under the HPLC conditions.Conclusion：The method is sensitive and specific , which could be used to detect the related substances in Ticagrelor Tablets.
出处
《中国药品标准》
CAS
2016年第3期198-203,共6页
Drug Standards of China
